Product Details
Amzeeq (minocycline) topical foam, 4% Rx only 30 g
Manufacturer: JOURNEY MEDICAL CORPORATION
MFG#: 69489-0201-30
NDC: 69489-0201-30
PID: 303558
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Description
Indications and Usage:
AMZEEQ is indicated for the topical treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in adults and pediatric patients 9 years of age and older [see Clinical Studies (14)].
Limitations of Use:
This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, AMZEEQ should be used only as indicated [see Warnings and Precautions (5.14)].
Product Properties:
| Description | S |
|---|---|
| Description | S |
| Description | - |
| DESI Drug Ind | - |
| DESI Drug Ind | -; - |
| DESI Drug Ind | -; - |
| DESI2 Drug Ind | - |
| Drug Category | S |
| Drug Category | USES: This medication is used to treat acne or rosacea. Minocycline belongs to a class of drugs known as tetracycline antibiotics. However, it is not used to treat skin infections. It helps decrease pimples and red bumps that happen with acne or rosacea. |
| Drug Category | USES: This medication is used to treat acne or rosacea. Minocycline belongs to a class of drugs known as tetracycline antibiotics. However, it is not used to treat skin infections. It helps decrease pimples and red bumps that happen with acne or rosacea. |
| Drug Type Code | COMMON BRAND NAME(S): Amzeeq |
| Drug Type Code | 1 |
| Drug Type Code | COMMON BRAND NAME(S): Amzeeq |
| FDA Approval Date | 10/18/2019 |
| FDA Therap Equiv | NR |
| HCPCS | - |
| HCPCS | 1 |
| HCPCS | 1 |
| Market Entry Date | 01/06/2020 |
| Medical Coverage | - |
| Medical Coverage | - |
| Medical Coverage | - |
| Termination Date | (MIN-oh-SYE-kleen) |
| Termination Date | (MIN-oh-SYE-kleen) |
| Termination Date | - |
| Unit | GM |
| Units Per Pkg | 30 |
| Active Ingredients | 2754 minocycline HCl 13614987 |
| Active Ingredients | 2754 minocycline HCl 13614987 |
| Active Ingredients | 2754 minocycline HCl 13614987 |
| AHFS Class | 84040400 ANTIBACTERIALS (SKIN, MUCOUS MEMBRANE) |
| AHFS Class | 84040400 ANTIBACTERIALS (SKIN, MUCOUS MEMBRANE) |
| AHFS Class | 84040400 ANTIBACTERIALS (SKIN, MUCOUS MEMBRANE) |
| DEA Class | NC |
| DEA Class | NC |
| DEA Class | NC |
| Dose Form | FOAM (GRAM) |
| Dose Form | FOAM (GRAM) |
| Dose Form | FOAM (GRAM) |
| Fine Line Class | 850085008510 All Rx Products |
| Fine Line Class | 850085008510 All Rx Products |
| Fine Line Class | 850085008510 All Rx Products |
| Gen Code and Des | 80360 minocycline HCl TOPICAL FOAM 4 % |
| Gen Code and Des | 80360 minocycline HCl TOPICAL FOAM 4 % |
| Gen Code and Des | 80360 minocycline HCl TOPICAL FOAM 4 % |
| Inactive Ingredients | 13405 soy; 16176 coconut; 9290 cremophor el (polyethoxlated castor oil) |
| Inactive Ingredients | 13405 soy; 16176 coconut; 9290 cremophor el (polyethoxlated castor oil) |
| Inactive Ingredients | 13405 soy; 16176 coconut; 9290 cremophor el (polyethoxlated castor oil) |
| OMP Family | - |
| OMP Family | - |
| OMP Family | - |
| Product Category | RX Pharmaceuticals |
| Product Category | RX Pharmaceuticals |
| Product Category | RX Pharmaceuticals |
| Strength | 4% |
| Strength | 4% |
| Strength | 4% |
| Common Brand Name | COMMON BRAND NAME(S): Amzeeq |
| Common Brand Name | - |
| Common Brand Name | - |
| Drug Interaction | - |
| Drug Interaction | DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. This medication may interfere with certain lab tests, possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug. |
| Drug Interaction | - |
| Allocation Period | - |
| Allocation Period | - |
| Allocation Period | - |
| Case Quantity | 12 |
| Case Quantity | 12 |
| Case Quantity | 12 |
| Drug Form Pack Size | 30 |
| Drug Form Pack Size | 30 |
| Drug Form Pack Size | 30 |
| Form | FOAM |
| Form | FOAM |
| Form | FOAM |
| Hazard Code | UN1950 AEROSOLS, FLAMMABLE, (EACH NOT EXCEEDING 1 L CAPACITY) |
| Hazard Code | UN1950 AEROSOLS, FLAMMABLE, (EACH NOT EXCEEDING 1 L CAPACITY) |
| Hazard Code | UN1950 AEROSOLS, FLAMMABLE, (EACH NOT EXCEEDING 1 L CAPACITY) |
| Listed Chemical | - |
| Listed Chemical | - |
| Listed Chemical | - |
| NIOSH Code | - |
| NIOSH Code | - |
| NIOSH Code | - |
| Orange Book | ZC Pharmaceutical entity and labeler evaluated but no therapeutic equivalence rating given. Usually applies to single source drugs. |
| Orange Book | ZC Pharmaceutical entity and labeler evaluated but no therapeutic equivalence rating given. Usually applies to single source drugs. |
| Orange Book | ZC Pharmaceutical entity and labeler evaluated but no therapeutic equivalence rating given. Usually applies to single source drugs. |
| Retail Pack Quantity | 1 |
| Retail Pack Quantity | 1 |
| Retail Pack Quantity | 1 |
| Returnable Status | Returnable |
| Returnable Status | Returnable |
| Returnable Status | Returnable |
| Special Storage Cond | 01 Aerosol |
| Special Storage Cond | 01 Aerosol |
| Special Storage Cond | 01 Aerosol |
| Temp Zone | 30 Refrige./DoNot Freez |
| Temp Zone | 30 Refrige./DoNot Freez |
| Temp Zone | 30 Refrige./DoNot Freez |
| Unit | EA |
| Unit | EA |
| Unit | EA |
| Unit Size | 30 |
| Unit Size | 30 |
| Unit Size | 30 |
| How to Use | - |
| How to Use | - |
| How to Use | HOW TO USE: Read the Patient Information Leaflet and Instructions for Use provided by your pharmacist before you start using minocycline foam and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Apply this product as directed by your doctor, usually once daily, at least 1 hour before bedtime. Do not bathe, shower, or swim for at least 1 hour after application. Before first use, allow the container to warm to room temperature. Do not warm up this medication any other way such as by heating in the microwave or placing in hot water. Wash your face gently with mild cleanser, rinse with water, and pat dry. Shake the container well before each use. Remove the cap, then press the top of the can to dispense a small amount of foam (about the size of a cherry) onto your fingertips. If you are using this medication to treat rosacea, apply and gently rub the foam over your entire face. If you are using this medication to treat acne, apply and gently rub the foam into the affected area(s) on your face. If you also have acne on other parts of your body (such as your neck, shoulders, arms, back, or chest), also apply the foam to these areas. Wash your hands after applying this medication. This product may stain fabric. This medication is for use on the skin only. To avoid irritation, do not let this medication come into contact with your eyes, inside your nose/mouth, or any broken skin (such as cuts, scrapes, rashes). If you do get the medication in those areas, flush the area with cool water. This product is flammable. Avoid fire, flame, and smoking during and right after applying this medication. Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day. Tell your doctor if your condition does not get better or if it gets worse. |
| Missed Dose | MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up. |
| Missed Dose | 30 |
| Missed Dose | 30 |
| Notes | GM |
| Notes | GM |
| Notes | NOTES: Do not share this medication with others. |
| Overdose | OVERDOSE: This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. |
| Overdose | NR |
| Overdose | NR |
| Phonetic Pronunciation | - |
| Phonetic Pronunciation | (MIN-oh-SYE-kleen) |
| Phonetic Pronunciation | - |
| Precautions | - |
| Precautions | PRECAUTIONS: Before using minocycline foam, tell your doctor or pharmacist if you are allergic to it; or to other tetracyclines (such as doxycycline); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history. This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness. This drug, when taken by mouth, can make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Children younger than 8 years may be more sensitive to the side effects of minocycline, especially tooth discoloration. Tooth discoloration has also occurred in older children and in young adults. Discuss the risks and benefits of this medication with the doctor. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if minocycline foam passes into breast milk. Consult your doctor before breast-feeding. |
| Precautions | - |
| Side Effects | - |
| Side Effects | - |
| Side Effects | SIDE EFFECTS: Skin redness, dryness, or itching may occur. Skin darkening that may be due to acne can also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Although these effects are unlikely when this medication is applied to the skin, serious side effects have rarely occurred with minocycline taken by mouth. Tell your doctor right away if you have any serious side effects, including: joint stiffness/pain/swelling, signs of kidney problems (such as change in the amount of urine), signs of liver problems (such as loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine), discoloration of skin/scars/lips/gums, yellow-gray-brown tooth discoloration. This medication may rarely cause a severe intestinal condition due to a bacteria called C. difficile. This condition may occur during treatment or weeks to months after treatment has stopped. Tell your doctor right away if you develop: diarrhea that doesn't stop, abdominal or stomach pain/cramping, blood/mucus in your stool. If you have these symptoms, do not use anti-diarrhea or opioid products because they may make symptoms worse. This medication may sometimes cause oral thrush or a new yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms. Minocycline may rarely cause increased pressure around the brain (intracranial hypertension-IH). The risk of this side effect is greater for women of childbearing age who are overweight or who have had IH in the past. If IH develops, it usually goes away after minocycline is stopped; however, there is a chance of permanent vision loss or blindness. Get medical help right away if you have: a headache that is severe or doesn't go away, vision changes (such as blurred/double vision, decreased vision, sudden blindness), nausea/vomiting that doesn't stop. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: fever, new or worsening lymph node swelling, rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. |
| Storage | STORAGE: Store at room temperature. Do not store in the refrigerator. Avoid fire, flame, or smoking since this product is flammable. Do not puncture or burn the container. Do not expose to high heat. After the container is opened, throw away any unused medication after 90 days. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company. |
| Storage | 10/18/2019 |
| Storage | 10/18/2019 |
| Uses | - |
| Uses | USES: This medication is used to treat acne or rosacea. Minocycline belongs to a class of drugs known as tetracycline antibiotics. However, it is not used to treat skin infections. It helps decrease pimples and red bumps that happen with acne or rosacea. |
| Uses | - |
Frequently Asked Questions (FAQs)
The cost of Amzeeq (minocycline) topical foam, 4% Rx only 30 g is $available for registerd members only
Amzeeq (minocycline) topical foam, 4% Rx only 30 g is manufactured by JOURNEY MEDICAL CORPORATION.
You can purchase Amzeeq (minocycline) topical foam, 4% Rx only 30 g on our website at https://supplies.pipelinemedical.com/product/detail/amzeeq-4-topical-fom-30-gm-303558